How many clinical trials are tracked for Autism Spectrum Disorder?

191 trials are tracked, 8 with published results.

Autism Spectrum Disorder Research

Autism Spectrum Disorder: what the trials found

Several established trials have investigated pharmacological interventions for autism spectrum disorder (ASD) and associated symptoms. In a phase 4 trial, atomoxetine showed no significant difference in ADHD response rates (45.2% vs 46.9% vs 29.0% vs 19.4%, p=0.47) or ASD response rates (22.6% vs 43.8% vs 38.7% vs 16.4%, p=0.95) compared to placebo ¹³. Another phase 3 trial of atomoxetine reported ADHD Rating Scale scores of 28.7 vs 34.0 and Vineland Adaptive Behavior Scales composite scores of 73.4 vs 74.9 ²⁰. A phase 4 trial of methylphenidate extended-release liquid formulation showed a mean change of -22.8 in Adult ADHD Investigator Symptom Report Scale score ⁸. For irritability, a phase 4 trial of aripiprazole was conducted ¹⁶, and a placebo-controlled trial found significant changes in Aberrant Behavior Checklist Irritability subscale (-3.5, -7.4, -12.4, p<0.001) and Clinical Global Impression Severity (-0.3, -0.4, -1.0, p<0.001) ¹⁷. A phase 3 trial of lurasidone (20-80 mg) reported changes from baseline in PANSS total score (76.0 to -11.9, -15.6, -18.4) and subscales ²². Other established trials include buspirone ¹⁰, milnacipran ¹¹, very low dose Quillivant XR ¹², minocycline ¹⁴, memantine ¹⁵ (with 15 participants showing reduction in ASD symptom severity ¹⁵), metformin ¹⁸, and memantine in another phase 3 trial ¹⁹. A phase 4 trial of open-label omega-3 fatty acids + inositol showed a mean change in Parent-Young Mania Rating Scale score of 0.0 to -2.6 ⁹. A phase 4 trial of Syntocinon (oxytocin) reported changes in brain activity via fMRI at 4, 8, and 52 weeks ⁷. A placebo-controlled trial found a mean 10-week change in Pediatric Anxiety Rating Scale of -4.9 vs -3.2 and response rates of 0.47 vs 0.20 ²¹.

For the clinician treating this condition

For irritability in ASD, aripiprazole and placebo-controlled data show significant improvements in Aberrant Behavior Checklist Irritability and Clinical Global Impression Severity ¹⁶¹⁷.
Atomoxetine did not demonstrate significant benefit over placebo for ADHD or ASD response rates in a phase 4 trial ¹³, though a phase 3 trial reported numerical differences in ADHD rating scores ²⁰.
Lurasidone (20-80 mg) showed dose-dependent reductions in PANSS total and subscale scores in a phase 3 trial ²².
Recent evidence suggests potential benefits of Sentido's Model for adaptive behavior and goal attainment ², and Flore for gastrointestinal symptoms ¹, but these findings are not yet corroborated.

AI synthesis of 21 cited trials, updated Jun 23, 2026. Informational only — not medical advice; trial data sourced from ClinicalTrials.gov. How we use AI.

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Questions about Autism Spectrum Disorder

Do specific autism neurosubtypes show opposite electrical brain activity patterns in preclinical models?

Research using animal models and human EEG data indicates that autism consists of distinct neurosubtypes with opposing electrical brain activity patterns related to excitation and inhibition balance.

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Does having different gut bacteria affect children with Autism Spectrum Disorder and ADHD?

Yes, children with ASD and ADHD often have different gut bacteria compared to neurotypical children, and this imbalance may influence symptoms and gut health.

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Autism Spectrum Disorder

Clinical Trials for Autism Spectrum Disorder

Autism Spectrum Disorder: what the trials found

Recent results — preliminary, needs further review

For the clinician treating this condition

Questions about Autism Spectrum Disorder